ISO 10993.2 pdf download.Biological evaluation of medical devices
1 Scope
This part of ISO 10993 specifies minimum requirements for the use of animals in biological testing. This part of ISO 10993 is also intended a) to establish guidelines which allow the scientist to respect life in general; b) to reduce the number of animal experiments and the number of animals used in experiments, among other ways by optimization of those performed; c) to minimize suffering and maintain the quality of life of the animals used in the experiments. This part of ISO 10993 applies to the experimentation performed on vertebrates. It does not apply to experimentation performed on less differentiated animals; nor does it apply to that part of the experimental work performed on isolated tissues and organs. This part of ISO 10993 also makes recommendations concerned with the aim of reducing the number of animals used for biocompatibility testing and when possible abolishing animal experiments in this area.
2 Normative reference
The following standard contains provisions which, through reference in this text, constitute provisions of this part of ISO 10993. At the time of publication, the edition indicated was valid. All standards are subject to revision, and parties to agreements based on this part of ISO 10993 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below. Members of IEC and ISO maintain registers of currently valid International Standards. ISO 10993-1:1992, Biological evaluation of medical devices — Part 1: Guidance on selection of tests.
3 Definitions
For the purposes of this part of ISO 10993, the definitions given in ISO 10993-1 and the following definitions apply. 3.1 animal any live non-human vertebrate, excluding foetal or embryonic forms, unless otherwise qualified 3.2 experimental animal animal used or to be used in experiments 3.3 bred animal animal specially bred for use in experiments in facilities accredited by, or registered with, the competent authority 3.4 animal experiment any use of an animal for scientific purposes which may cause it pain, anxiety, suffering, distress or lasting harm, excluding the least painful methods accepted in modern veterinary or laboratory practice (i.e. “humane” methods) of killing or marking an animal an experiment starts when an animal is first prepared for use and ends when no further observations are to be made for that experiment NOTE 1 The prevention, elimination and minimization of pain, suffering, distress or lasting harm by the successful use of anaesthesia or analgesia or other methods does not place the use of an animal outside the scope of this definition.3.5 competent authority that authority designated by each state as being responsible for supervising the experiments within the scope of this part of ISO 10993 3.6 properly anaesthezized deprived of sensation by methods of anaesthesia (whether local or general) as effective as those used in good veterinary practice 3.7 humane method of killing killing of an animal with a minimum of physical and mental suffering NOTE 2 Appropriate means will vary according to the animal species. 3.8 unnecessary repetition duplication of the same experiment without scientific need
4 Requirements
NOTE 4 See Annex A for bibliographical references. 4.1 Sequence of in vitro and in vivo tests Animal experiments shall not be performed before appropriate in vitro tests, if available, have been carried out. If the in vitro tests clearly show that the material, device or extract is unsuitable the animal experiment shall not be performed. 4.2 Prevention of unnecessary repetition Scientists proposing to conduct biological evaluation tests shall make diligent efforts to ascertain that any proposed animal experiments have not been done previously. Scientists conducting biological evaluation tests are encouraged to publish the results of their experiments including negative ones in internationally referenced journals, using key words that allow identification or relevant animal experiments. Licensing authorities are to be encouraged to establish specific lines of communication directed toward preventing unnecessary repetition. (See 5.2.) 4.3 Availability of results It is strongly recommended that the results of appropriately performed and evaluated tests be accepted by all countries.